FDA Defines the "Term Quality Unit"

GMP News No. 833

GMP News
9 November 2006

FDA Defines the "Term Quality Unit"

Up to now, the terms Quality Control, Quality Control Unit, Quality Unit were not exactly defined in FDA's rules and regulations. Clear statements regarding independence or analogies were missing. For example it was not obvious who is responsible for the quality system, controls and release.

The Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulation does now try to define these terms more precisely. The document defines the Quality Unit as the concept which "is also consistent with modern quality systems in ensuring that the various operations associated with all systems are appropriately planned, approved, conducted and monitored".

Assigned responsibilities are for example:

  • Ensuring that controls are implemented and completed satisfactorily during manufacturing operations
  • Ensuring that developed procedures and specifications are appropriate and followed
  • Approving and rejecting incoming materials, in-process materials and drug products
  • Reviewing production records and investigating any unexplained discrepancies

Responsibilities are divided between quality control (QC) and quality assurance functions (QA). The QC usually assesses suitability of components and products, evaluates the performance of the manufacturing process with respect to specifications and limits and determines the acceptability of each batch for release, The QA reviews and approves procedures, reviews records and performs audits and trend analyses.

Nevertheless, the FDA does not move away from the term Quality Control Unit (QCU), which is defined in CFR §210.3(b)(15) and described in §211.22. This still leaves a bit of ambiguity. According to CFR §210.3, the Quality Control Unit is responsible for the duties relating to quality control, whereas according to §211.22, the QCU has the responsibility to approve or reject.

The Guidance was published 29 September 2006 (see news from 05 October 2006) and contributes to the goals of the FDA's "cGMPs for the 21st Century" and "Critical Path Initiative" (www.fda.gov/oc/initiatives/criticalpath/) which seek to modernise the development of new drugs.

The full text of the guidance can be found at:

In the following ECA 2-day education course you will find out more about the FDA and its expectations:

FDA – What You Need to Know: Organisation, Inspection, Application and Approval

26 -27 April 2007 also in Prague, Czech Republic
Wolfgang Schmitt
On behalf of ECA

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